The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories

NCT ID: NCT03875391

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2021-03-31

Brief Summary

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The purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.

Detailed Description

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Conditions

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Intrusive Memories PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin and trauma film paradigm

Intervention: Drug: Oxytocin nasal spray

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Drug: Oxytocin nasal spray

Placebo and trauma film paradigm

Intervention: Drug: Placebos

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug: Placebo nasal spray

Interventions

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Oxytocin

Drug: Oxytocin nasal spray

Intervention Type DRUG

Placebo

Drug: Placebo nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy female volunteers
* German on a native level

Exclusion Criteria

* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* any physical illnesses
* any medication intake (except oral contraceptive)
* history of traumatic experience, e.g. history of sexual abuse or rape
* pregnancy or lactation period
* follicular phase of menstrual cycle for all women not using oral contraceptives
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Stefan Roepke

Principal Investigator, PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Roepke, Prof

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

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Charité- Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Maslahati T, Wingenfeld K, Hellmann-Regen J, Kraft J, Lyu J, Keinert M, Voss A, Cho AB, Ripke S, Otte C, Schultebraucks K, Roepke S. Oxytocin vs. placebo effects on intrusive memory consolidation using a trauma film paradigm: a randomized, controlled experimental study in healthy women. Transl Psychiatry. 2023 Feb 4;13(1):42. doi: 10.1038/s41398-023-02339-z.

Reference Type DERIVED
PMID: 36739422 (View on PubMed)

Other Identifiers

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Charite2019-Oxytocin-Study

Identifier Type: -

Identifier Source: org_study_id

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